05:18 PM EST, 11/24/2025 (MT Newswires) -- Bristol Myers Squibb ( BMY ) said late Monday that the European Commission has approved its CAR T therapy Breyanzi for adults with relapsed or refractory mantle cell lymphoma who have had at least two prior treatments, including a BTK inhibitor.

The approval follows the TRANSCEND MCL trial, in which Breyanzi achieved an 82.7% overall response rate, 71.6% complete responses, and 50.8% of patients maintained their response at 24 months.

Safety findings aligned with previous studies, with most cytokine release syndrome and neurological events occurring within 14 days of infusion.